Deviation Management Specialist - I (Assistant)

Nesco Resource • West Point, PA

1d

About The Position

The Deviation Management Specialist supports resolution and reduction of process deviations, development and implementation of corrective and preventive actions, and manufacturing and laboratory investigations. The role provides technical and scientific support on the production floor for manufacturing areas within the Manufacturing Division. It also works with counterparts supporting aseptic manufacturing, testing, planning, and release, applying scientific and engineering principles to investigate process deviations. The position includes troubleshooting laboratory test failures and manufacturing atypical events, performing root cause analysis, and developing corrective and preventive actions. It also involves analyzing complex problems and designing and executing laboratory- or pilot-scale experiments.

Requirements

• B.S. or M.S. degree in an appropriate engineering or scientific field.
• At least 1–3 years of post-bachelor’s experience in a cGMP environment, such as Production, Development, Process Engineering, Technical Services, or a related field, in the pharmaceutical or biotechnology industry; academic or internship experience is accepted.
• Previous experience writing investigations, conducting root cause analysis, and developing corrective and preventive actions for atypical events in a manufacturing environment.
• Familiarity with Lean Six Sigma methodologies and demonstrated analytical and problem-solving capabilities.
• Ability to work independently and as part of a cross-functional team.
• Excellent technical/scientific writing and verbal communication skills.

Responsibilities

• Resolve and reduce process deviations.
• Develop and implement corrective and preventive actions.
• Lead manufacturing and laboratory investigations.
• Provide technical and scientific support on the production floor for manufacturing areas within the Manufacturing Division.
• Develop working relationships with counterparts supporting aseptic manufacturing, testing, planning, and release.
• Apply scientific and engineering principles to investigate process deviations.
• Troubleshoot laboratory test failures and manufacturing atypical events, conduct root cause analysis, and develop corrective and preventive actions.
• Analyze complex problems through critical analytical thinking and design and execute laboratory- or pilot-scale experiments.

Benefits

• Medical coverage through a Minimum Essential Coverage (MEC) plan
• Vision insurance
• Dental insurance
• 401(k)
• Employee Assistance Program (EAP) services

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level